Fortrea is a leading global Contract Research Organization (CRO) committed to advancing scientific innovation and clinical development. With operations in nearly 100 countries, Fortrea partners with pharmaceutical, biotechnology, and medical device companies to provide clinical development, patient access, and technology solutions across more than 20 therapeutic areas. With a mission to revolutionize drug and device development, Fortrea plays a pivotal role in delivering life-changing therapies to patients worldwide.
Responsibilities in Job
Safety Science Coordinator II
- Manage the receipt and processing of adverse event (AE) reports from various sources, including clinical trials.
- Enter safety data into adverse event databases and ensure accuracy for expedited reporting.
- Write patient narratives and accurately code adverse events using MedDRA.
- Identify missing clinically significant information and generate queries for its collection.
- Ensure cases receive appropriate medical review and prioritize submissions to regulatory agencies and other stakeholders within required timelines.
- Handle expedited Safety Reports (ESRs), Periodic Safety Reports (PSRs), and ensure timely submission to regulatory authorities, ethics committees, and other stakeholders.
- Support database reconciliation and quality reviews of processed reports.
- Maintain compliance with Standard Operating Procedures (SOPs) and Work Instructions (WIs).
- Assist in preparing client meetings, audit inspections, and quality issue management.
- Train and mentor team members and contribute to metrics reporting.
Safety Science Specialist
- Manage receipt and processing of AE reports and ensure completeness, accuracy, and appropriateness.
- Write patient narratives, code AEs using MedDRA, and ensure accurate listedness against labels.
- Process expedited SAE reports and ensure timely submissions to regulatory authorities and other parties.
- Reconcile safety databases with the Data Management team.
- Perform quality reviews of processed reports and provide actionable insights to management.
- Prepare safety study files for archiving and support CAPA plan development.
- Participate in audits and inspections, supporting root cause analysis and quality issue resolution.
Qualifications
Safety Science Coordinator II
- 2-3 years of relevant experience in clinical trial case processing.
- Degree in Biological Sciences, Pharmacy, Nursing, Medical Sciences, Life Sciences, or related disciplines preferred.
Safety Science Specialist
- Minimum of 3 years of pharmacovigilance experience with clinical trial case processing expertise.
- Strong knowledge of safety management processes and regulatory requirements.
Skills
- Proficiency in adverse event database management.
- Strong understanding of MedDRA coding and safety reporting.
- Excellent analytical and communication skills.
- Ability to manage multiple priorities and meet strict deadlines.
- Knowledge of global pharmacovigilance regulations and guidelines.
- Proficiency in SOPs, WIs, and other procedural documents.
- Team collaboration and leadership abilities.
Safety Science Coordinator II: Application Link
Safety Science Specialist: Application Link
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